Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT04993053

Collaborator

(none)

Enrollment

Location

14.9

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Intramedullary nailing is the standard treatment of trochanteric fractures. Mechanical failure such as cut-out and cut-through are associated with high rates of revision surgery, functional impairment and mortality. Augmentation of the implant have shown encouraging results in reducing the number of mechanical failures. The aim of the study was to evaluate the rate of mechanical failure of the cement augmented screws of TFNA nails.

A descriptive, retrospective, multi-operator, single-centre study was performed at our level 1 trauma centre. Patients were included if they were > 65 years of age, presented with a trochanteric fracture treated with an augmented TFNA nail. The primary outcome was fixation failure rate (cut-out or cut-through) at 3 and 6 postoperative months. Secondary endpoints were intraoperative data, clinical scores, and radiographic analysis.

Condition or Disease	Intervention/Treatment	Phase
the Cement Augmented Screws of TFNA Nails

Study Design

Study Type:

Observational

Actual Enrollment :

61 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures in Patients Over 65 Years of Age

Actual Study Start Date :

Jun 20, 2019

Actual Primary Completion Date :

Jun 3, 2020

Actual Study Completion Date :

Sep 15, 2020

Outcome Measures

Primary Outcome Measures

Fixation failure rate (cut-out or cut-through) [change at 3 and 6 postoperative months]
On X rays

Secondary Outcome Measures

Visual Analogue Scale score [at 3 and 6 postoperative months]
the minimum is 0 and maximum 10, higher scores mean a worse outcome.
analysis evaluating quality of reduction [once]
On X rays
Augmentation volume [once]
length of surgery [at 3 and 6 postoperative months]
radiation exposure [once]
duration of hospitalisation [once]
Intraoperative adverse events [once]
EuroQoL 5-Dimensions score [change at 3 and 6 postoperative months]
the minimum is 5 and maximum 15, higher scores mean a worse outcome.
Parker Mobility Score [at 3 and 6 postoperative months]
the minimum is 0 and maximum 9, higher scores mean a better outcome.
Harris Hip Score [at 3 and 6 postoperative months]
the minimum is 0 and maximum 100, higher scores mean a betteroutcome.
the tip-apex distance [once]
On X rays
TFNA screw position [once]
On X rays
distribution of cement on either side of the cervicocephalic screw [once]
On X rays
postoperative complications [at 3 and 6 postoperative months]
the need for revision surgery [at 3 and 6 postoperative months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

65 years of age
a trochanteric fracture that occurred through a low-energy mechanism
an augmented TFNA nail

Exclusion Criteria:

pathological fracture
open fracture
hips with pre-existing deformities other than osteoarthritis
a history of hip surgery
an insufficient quantity of injected cement (< 3 mL).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Brest	Brest		France	29609

Sponsors and Collaborators

University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT04993053

Other Study ID Numbers:

TFNA - 29BRC21.0076

First Posted:

Aug 6, 2021

Last Update Posted:

Aug 6, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Brest

Additional relevant MeSH terms:

Fractures, Bone

Study Results

No Results Posted as of Aug 6, 2021